KCI USA Recalls 1000 ml Canisters for Negative Pressure Wound Therapy Systems
KCI USA is recalling 5,385 cases of 1000 ml canisters for InfoV.A.C. and V.A.C.ULTA systems due to a potential sterile barrier breach.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential sterile barrier breach in a medical device used for wound management, which poses a risk of harm without reported injuries.
Plain-English summary
KCI USA, INC. is recalling 5,385 cases of 1000 ml Canisters (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems. The affected product, identified by Part Number M8275093/5, is an integrated wound management system used in acute and extended care settings to promote wound healing by creating a negative pressure environment.
The recall was initiated due to a potential sterile barrier breach. The canisters are intended to collect exudates and infectious materials from open wounds or closed surgical incisions. A breach in the sterile barrier could compromise the integrity of the wound management environment.
The affected units were distributed nationwide in the United States and internationally to the Dominican Republic, Ecuador, Guatemala, Mexico, Panama, Austria, Estonia, Germany, Switzerland, Japan, and Malaysia. Specific lot codes associated with the recall include 51020446, 51020448, 51020449, 51020750, 51020751, 51020752, 51020753, 51020856, 51021472, 51021936, 51021938, 51021939, 51021940, 51022283, 51022440, 51022441, and 51022719. Healthcare providers and facilities should check their inventory for these specific part numbers and lot codes and contact the manufacturer for instructions on returning or replacing the affected units.
The recalled product
- Product
- 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended
- Manufacturer
- KCI USA, INC.
- Category
- Medical Device — Wound Care
- Affected units
- 5,385
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 51020446
- 51020448
- 51020449
- 51020750
- 51020751
- 51020752
- 51020753
- 51020856
- 51021472
- 51021936
- 51021938
- 51021939
- 51021940
- 51022283
- 51022440
- 51022441
- 51022719
Distribution
Distributed nationwide across the United States.
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